Swivel Adapter for Nebulizer

ABSTRACT

An adapter tube is provided with a pivotally flexible swivel joint providing an aerosol-conducting airway for use with an inhalation mask with a nebulizer.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority under 35 U.S.C. §119(e) to U.S.Provisional Patent Application No. 61/485,036, filed May 11, 2011, thecontents of which are hereby incorporated by reference.

FIELD OF THE INVENTION

This invention pertains to medical devices for the inhalation of drugsinto the lungs.

BACKGROUND

In the field of respiratory devices, nebulizers are important devicesused for the inhalation of drugs in the form of an aerosol. A nebulizeremploys an apparatus that generates an aerosol or mist from a solution(usually an aqueous solution) or suspension of a drug. The mist may bean aerosolized suspension or an atomized suspension of drug, meaningmicro-droplets suspended in air, medical oxygen, or other inhalable gas.The aerosol is conveyed to the mouth and/or nose of a patient andinhaled into the lungs. In some cases, the mist is conveyed to the lungsthrough a mouthpiece. In other cases, the nebulizer may be coupled to aninhalation mask.

Nebulizers operate by passing a stream of air or other suitable gas,such as medical oxygen, over or through a reservoir holding an aqueoussolution of a drug for inhalation. In many cases, a stream ofpressurized gas enters the nebulizer through a gas inlet and through ajet to produce a Venturi effect that draws a stream of the solutionthrough a narrow passage or capillary from a pressure differential,whereby the liquid enters the jet and becomes atomized. Typically, abaffle is employed in the jet effluent that prevents large droplets fromexiting the device, so that only aerosol micro-droplets of drugcontaining solution exit the device. An example of such a nebulizer isdisclosed in U.S. Pat. No. 4,588,129. The aerosol is then inhaled by thepatient. Typically, the aerosol production is continuous, so a vent istypically provided to ensure that the pressure differential created bythe jet operates continuously and consistently.

The drug reservoir in nebulizers is usually a cone, cup, or bowl-shapedvessel into which a sterile aqueous solution of the drug is added.Accordingly, the orientation of the nebulizer is important, and thedevice must be kept approximately in an orientation such that thedrug-containing solution stays in the reservoir where it can beaerosolized in the nebulizer. This restricts the range of motionavailable to the patient and nebulizer during use.

Typical drugs used with nebulizers are drugs for the treatment of asthmaand obstructive pulmonary diseases, but other pulmonary and systematicmedications may be administered by inhalation with nebulizers. Forexample, albuterol (called salbutamol in many countries), used fortreating asthma and bronchospasm, may be administered as a nebulizedsolution. Another example is pentamidine, a drug used to treatPneumocystis pneumonia (PCP).

Nebulizers are particularly useful for the administration of inhaleddrugs to small children, elderly, unconscious, or disabled patients whocannot coordinate their breathing or take instruction on the use ofcoordinated inhalation devices, such as a metered dose inhaler. With anebulizer, the dose of drug is administered to the patient over a periodof several minutes, and possibly ten to twenty (or more) tidal or slowdeep inhalations per minute, so breathing coordination is not required.

In the case of patients who cannot hold a mouthpiece in their mouth, aninhalation mask may be used with a nebulizer. This creates acomplication in that the orientation of the mask and the nebulizerapparatus is important, to maintain the drug-containing solution in thereservoir for nebulization. Most nebulizer masks currently on the markethave relatively inflexible connectors from the mask to the nebulizerapparatus and typically have a corrugated tube with a fixed 90° elbowfor connection to a nebulizer. This requires that the patient inhale themist while sitting straight in order to keep the nebulizer approximatelyvertical to avoid spilling the drug solution in the nebulizer or havingthe solution flow away from the capillary that carries the drug to theair-jet of the Venturi.

SUMMARY OF THE INVENTION

In one aspect, there is provided a swivel adapter for use as an airwaywith a nebulizer for inhaled drugs, wherein the adapter has a 90° elbowsection, including a flanged joint comprising a frusto-spherical malesection embedded in a matching frusto-spherical female section, that ispivotally flexible and can swivel over a broad range of angles andmaintain a rigid airway at any angle. This apparatus with aball-and-socket type of joint fits on the aerosol outlet of a nebulizerand allows a mouthpiece or mask to be adapted to the patient's mostcomfortable position while keeping the nebulizer in a roughly verticalorientation. In an embodiment, a method of using a nebulizer with a tubewith a swivel adapter and a 90° elbow section, including a flangedjoint, is provided. The adapter is used to convey an aerosolized drugfrom a nebulizer to the respiratory tract of a patient via inhalationthrough the nose and/or mouth.

DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are perspective views of a complete nebulizer andinhalation mask apparatus including the inventive swivel adapter.

FIGS. 2A and 2B are perspective views of a complete nebulizer andmouthpiece apparatus including the inventive swivel adapter.

FIGS. 3A and 3B are perspective views of the inventive device.

FIG. 4 is a side elevation view of the inventive device.

FIG. 5 is a side elevation view with the linear tubular member flexedapproximately 15°.

FIG. 6 is a perspective view of the linear tubular member.

FIG. 7 is a perspective view of the 90° elbow tube member.

FIG. 8 is a cross-sectional view of the linear tubular member.

FIG. 9 is a cross-sectional view of the 90° elbow tube member.

FIG. 10 is a cross-sectional view of the inventive device, showing the90° elbow tube member nested into the flange of the linear tubularmember.

FIG. 11 is a perspective view of an alternative embodiment of thisinvention with a ribbed seat in the joint providing venting.

FIG. 12 is a cross-section of the embodiment with a ribbed seat in thejoint providing venting.

FIG. 13 is a perspective of the linear tubular member with a ribbed seatin the joint providing venting.

FIG. 14 is a cross section of the linear tubular member with a ribbedseat in the joint providing venting.

FIG. 15 is a cutaway view of the linear tubular member with a ribbedseat in the joint providing venting.

DETAILED DESCRIPTION

In an embodiment, this invention discloses an adapter tube for use witha nebulizer for an inhalable drug, wherein the adapter comprises apivotally flexible swivel joint that can swivel in any direction up toabout 45° from its normal position, by use of a ball-and-socket type offlanged connector that provides a rigid airway regardless of the angleof use. The inhalable drug may be any drug intended for administrationto the respiratory tract or lungs of a patient in need of such drug.

As used in the discussion herein, the term “proximal” means the section,orientation, or part closest to the face of a patient. The term “distal”means the section, orientation, or part closest to the nebulizer. Thus,the aerosol effluent from a nebulizer flows from the distal to theproximal end of the adapter in use.

Referring to the drawings, the embodiment in FIGS. 3-10 provides anadapter tube 10 defining a rigid aerosol-conducting airway with a swiveljoint comprising of a ball-and-socket type of joint with a high degreeof pivotal flexibility. The adapter 10 has two major components, 90°elbow tube member 100, and linear tubular member 200, arranged so thatthe proximal end of 100 comprises a frusto-spherical shape 130, alsotermed a nipple, on the outer surface of the proximal end. Member 200comprises a cup-like frusto-spherical shape 230 on the inner surface ofits distal end. Surface 130 nests inside of surface 230, as shown incross-section in FIG. 10. When the nipple is nested in the cup, member200 can pivot in any direction with respect to member 100 within auniversal and continuous range of motion of approximately 45° in anydirection. Member 200 is illustrated bent approximately 15° as 12 inFIG. 5. Member 200 is illustrated in FIG. 4 with no bend; that is, theangle measured through and along the axis of the pivotally flexiblejoint is 0° in FIG. 4. At all angles, the adapter 10 provides a rigidairway around the ball-and-socket pivotally flexible joint. In someembodiments, there is a tight seal preventing air leakage around theball-and-socket pivotally flexible joint regardless of the pivot angle,preventing loss of drug through the joint.

As shown in the embodiment of FIGS. 3-10, the distal end of member 100comprises tubular section 110 that defines airway 150 which is connectedto the outlet of a nebulizer. The section 110 is intended to make afemale connection to a nebulizer male aerosol outlet. Member 100 has 90°elbow bend portion 160 proximal to tube 110. Frusto-spherical section130 is proximally oriented with respect to section 160.

As shown in the embodiment of FIGS. 3-10, the proximal end 210 of member200 defines an airway 250 that is connected to a mouthpiece orinhalation mask as a male connector that conveys an aerosolized druginto the mouth or nose of a patient. The distal end of member 200comprises a bulbous section 232 with an interior surface 230 defining afrusto-spherical shape, within which surface 130 nests in the completeadapter 10. Member 200 may optionally employ an annular flange 240 toassist in proper positioning of the mouthpiece or inhalation mask.Flange 240 may also be useful in providing a manual grip on the adapterwhen inserting the adapter 10 on to a nebulizer or into a mouthpiece orinhalation mask.

Thus, in an embodiment, an adapter tube is provided defining anaerosol-conducting airway with a pivotally flexible swivel joint for theuse with an inhalation mask or mouthpiece with a nebulizer for theadministration of an inhaled drug to the respiratory tract of a patient,where the adapter tube includes a first 90° elbow tube member with aninterior surface and outer surface, a distal leg and a proximal leg,wherein the distal leg and proximal leg are oriented at a 90° angle, andthe distal leg comprises a cylindrical section adapted for fitting on toa nebulizer, and the proximal leg comprises a frusto-spherical convexouter surface; a second linear tubular member with an interior surfaceand outer surface, a distal section and a proximal section, wherein thedistal section comprises a concave frusto-spherical flange on theinterior surface of the distal section of said tubular member, andwherein the proximal section is adapted for fitting into an inhalationmask or mouthpiece; and the proximal outer-surface frusto-sphericalsection of the 90° elbow member fits inside the distal frusto-sphericalflange of the linear tubular member to form a pivotally-flexible swiveljoint providing a rigid pivotally flexible airway for conveying anaerosolized drug to the respiratory tract of the patient.

In an embodiment, the orientation of the pivotally-flexibleball-and-socket connection may be reversed; that is, the femalefrusto-spherical section (the “socket” component) may be on the elbowmember corresponding to member 200, and the male frusto-sphericalsection (the nipple or “ball” component) may be on the tubular sectioncorresponding to member 100.

The adapter as disclosed herein may optionally include vent openings,illustrated in the drawings as 140, that may be necessary to equalizethe pressure within the device, so that the nebulizer jet creates thedesired pressure differential (Venturi effect) to draw thedrug-containing solution into the jet where it is nebulized. In the caseof continuous nebulization, vents are required to equalize the pressureand carry the aerosol away from the patient. In other embodiments, forexample with a breath-actuated nebulizer, no vent holes will beprovided. In some embodiments, including that shown in FIGS. 3-10, theball-and-socket swivel joint makes a tight seal, which may be importantin some applications, for example with the use of a breath-actuatednebulizer.

Thus, the adapter 10 can be used with a conventional continuousnebulizer, or with a breath-actuated nebulizer. In a conventionalcontinuous nebulizer, a steady flow of aerosol is produced. In suchdevices, the mouthpiece is typically vented, keeping the pressurebalanced in the nebulizer, but permitting aerosolized drug to escapefrom the device. With many drugs (for asthma therapy, for example) theescape and wasting of drug aerosol is not a problem, particularly if thedrug is inexpensive and non-sensitizing.

Other vent configurations are also possible besides a type ofconfiguration depicted as 140 in the Figures. For example, vent openingscan be elsewhere on the adapter. In an embodiment, there may be ventopenings within the ball-and-socket pivotally flexible joint.

An alternative embodiment 14 of the inventive adapter is shown in FIGS.11-15, providing a ribbed seat in the ball-and-socket joint thatprovides venting in the adapter. As shown in FIGS. 11-15, a 90° elbowmember 100 with a convex frusto-spherical nipple shape 130 on theproximal end similar to FIGS. 7 and 9 is employed, but without ventopenings 140. The linear tubular member 202 in this embodiment has afrusto-spherical portion 232 at the distal end, but the cup-like portionof member 202 has ribs 250 in the interior surface in which nipple 130is seated. This is shown in perspective in FIG. 11 and in cross sectionin FIG. 12. The interior surface 255 of the cup-like distal portion ofmember 202 creates vent openings 252 in the assembled embodiment 14. Thevents 252 provide fluid communication between 212, the proximal interiorportion of member 202, and the exterior of the adapter 14. FIG. 13 is aperspective view of member 202, showing the ribs extending the fulllength of interior surface 255. FIGS. 14 and 15 show the ribs extendingthe full length of interior surface 255 to cylindrical interior surface212. As is illustrated in FIG. 12, surface 130 when seated does notextend fully into the cup-like portion of 202, so the vent openingsdefined by ribs 250 are not blocked by surface 130.

In an alternative, the opposite arrangement to FIGS. 11-15 may beemployed (not shown), with the nipple on the linear tubular member andthe cup-like portion on the 90° elbow member.

In recent years, breath-actuated nebulizers have become available, forexample the “AeroEclipse®” available in the United States from MonaghanMedical Corporation. These devices have a mechanism that preventsaerosolization within the device except when the patient is actuallyinhaling. There is no free vent allowing un-inhaled drug to escapeduring exhalation. Such devices are particularly useful where either thecost of the drug is very high or when the drug is sensitizing tocaregivers (e.g. antibiotics), making wastage undesirable.Breath-actuated nebulizers are also useful where the dose of inhaleddrug is critical, since without the wastage of a conventional nebulizer,the care-giver can be more certain of the amount of drug actuallyinhaled by the patient.

Also disclosed herein is a method of using a nebulizer with an adapterinterposed between the nebulizer body and a mouthpiece or inhalationmask, allowing a degree of flexibility in the positioning of the devicerelative to the patient using the device. In an embodiment, this mayprovide a more comfortable position for the patient, since a nebulizer(as noted above), must typically be maintained in an approximatelyvertical orientation so that the drug-containing solution is properlyoriented in the reservoir for nebulization. In most cases, nebulizersare cylindrical in shape and must be kept in an approximately verticalorientation in use. Thus, the pivotally flexible adapter may provide amore comfortable position for a patient. In another embodiment, thepatient may be incompetent (unable to take instructions even to sit up)or unconscious. In such cases, in which an inhalation mask wouldnormally be used, the inventive adapter gives caretakers enhancedflexibility in orienting the patient and/or the nebulizer for effectiveadministration of the drug.

The adapter with an inhalation mask is shown in FIG. 1, whichillustrates a complete kit of nebulizer 20, adapter 10 according to thisdisclosure, and an inhalation mask 30 that fits over the nose and mouthof a patient. Two views of the mask embodiment are shown in FIG. 1. FIG.1A shows a view of the opening of the mask, that covers the nose andmouth of the patient. FIG. 1B shows the back view of the same apparatusas shown in FIG. 1A. Also shown in FIG. 1B are optional vents 140.

As shown in FIGS. 2A and 2B, the adapter 10 may be used with amouthpiece 40 connected to tubular portion 210 (not marked). Suchmouthpieces are well known in the art of using nebulizers, and simplyconvey the aerosol to the mouth of a patient for inhalation into therespiratory tract. The use of a mouthpiece is less expensive and easierfor a caregiver if the patient is competent to take instructions toinhale through the mouth with the mouthpiece inserted between the closedlips and teeth.

1. An adapter tube defining an aerosol-conducting airway with apivotally flexible swivel joint for the use with an inhalation mask ormouthpiece with a nebulizer for the administration of an inhaled drug tothe respiratory tract of a patient, said adapter tube comprising: a. afirst 90° elbow tube member with an interior surface and outer surface,a distal leg and a proximal leg, wherein the distal leg and proximal legare oriented at a 90° angle, and the distal leg comprises a cylindricalsection adapted for fitting on to a nebulizer, and the proximal legcomprises a frusto-spherical convex outer surface; b. a second lineartubular member with an interior surface and outer surface, a distalsection and a proximal section, wherein the distal section comprises aconcave frusto-spherical flange on the interior surface of the distalsection of said tubular member, and wherein the proximal section isadapted for fitting into an inhalation mask or mouthpiece; and c. theproximal outer-surface frusto-spherical section of the 90° elbow memberfits inside the distal frusto-spherical flange of the linear tubularmember to form a pivotally-flexible swivel joint providing a rigidpivotally flexible airway for conveying an aerosolized drug to therespiratory tract of the patient.
 2. The adapter tube of claim 1,wherein the drug is administered to the lungs of the patient.
 3. Theadapter tube of claim 1, wherein the linear tubular member furthercomprises an annular flange interposed between the distal and proximalleg portions.
 4. The adapter tube of claim 1, wherein thepivotally-flexible swivel joint provides an airtight seal, withessentially no air leakage at the site of the joint.
 5. The adapter tubeof claim 1, wherein the 90° elbow tube member further comprises airvents.
 6. A method of using a nebulizer, comprising interposing anadapter tube according to claim 1 between an inhalation mask ormouthpiece and the nebulizer vaporization apparatus, such that thenebulizer is in fluid communication with the inhalation mask ormouthpiece.
 7. The method of claim 6 wherein the inhalation mask ormouthpiece is used in an angle other than a 0° angle measured along theaxis of the pivotally flexible swivel joint.
 8. An adapter tube definingan aerosol-conducting airway with a pivotally flexible swivel joint forthe use with an inhalation mask or mouthpiece with a nebulizer for theadministration of an inhaled drug to the respiratory tract of a patient,said adapter tube comprising a. a first 90° elbow tube member with aninterior surface and outer surface, a distal leg and a proximal leg,wherein the distal leg and proximal leg are oriented at a 90° angle, andthe distal leg comprises a cylindrical section adapted for fitting on toa nebulizer, and the proximal leg comprises concave frusto-sphericalflange on the interior surface; b. a second linear tubular member withan interior surface and outer surface, a distal section and a proximalsection, wherein the distal section of said tubular member comprises afrusto-spherical convex outer surface, and wherein the proximal sectionis adapted for fitting into an inhalation mask or mouthpiece; and c. thedistal frusto-spherical outer surface of the linear tubular member fitsinside the proximal inner-surface frusto-spherical section of the 90°elbow member to form a pivotally flexible swivel joint providing a rigidpivotally flexible airway for conveying an aerosolized drug to therespiratory tract of the patient.
 9. An adapter tube defining anaerosol-conducting airway with a pivotally flexible swivel joint for theuse with an inhalation mask or mouthpiece with a nebulizer for theadministration of an inhaled drug to the respiratory tract of a patient,said adapter tube comprising: a. a first 90° elbow tube member with aninterior surface and outer surface, a distal leg and a proximal leg,wherein the distal leg and proximal leg are oriented at a 90° angle, andthe distal leg comprises a cylindrical section adapted for fitting on toa nebulizer, and the proximal leg comprises a frusto-spherical convexouter surface; b. a second linear tubular member with an interiorsurface and outer surface, a distal section and a proximal section,wherein the distal section comprises a concave frusto-spherical flangeon the interior surface of the distal section of said tubular member,and said interior surface comprises three or more ribs, and the proximalsection is adapted for fitting into an inhalation mask or mouthpiece;and c. the proximal outer-surface frusto-spherical section of the 90°elbow member fits inside the ribs of the distal frusto-spherical flangeof the linear tubular member to form a pivotally-flexible swivel jointproviding a rigid pivotally flexible airway for conveying an aerosolizeddrug to the respiratory tract of the patient, wherein said ribs definevent openings in fluid communication with the tubular proximal sectionof the linear tubular member and the exterior of the adapter tube.